FDA Inspection Response (482d)

QI / food-safety-manager workflow for handling an FDA records request. Covers logging the inspection, attaching the affected partners, marking the 482d received, downloading the response package per partner (HA + Evaluation + Verification Worksheet PDFs plus supporting documents), drafting the formal response email, marking the inspection responded, and closing it with an outcome. Form 482d is a written records request issued under 21 CFR 1.510(b) — distinct from Form 483a, which records observations from an in-person inspection. Both can be logged here, but the typical FSVP scenario is the 482d records request, which the QI must respond to in writing with the documented FSVP file for each named foreign supplier.

Who: Qualified Individual (QI) / Food Safety Manager · Regulation: 21 CFR 1.510 (Records availability), Form 482d (records request)

Log the FDA inspection in the system

What you should see: The inspection is created with status “Open” and the page opens to its detail view. A reference number (e.g. INSP-2026-0001) is auto-assigned and used as the audit-trail anchor for the rest of this chapter.

Attach the affected partner to the inspection

What you should see: The partner appears in the Affected Partners table with its country, and the section heading count increases. From this point, every action — package download, response draft — operates on the attached partners.

Mark the 482d records request as received

What you should see: A confirmation toast reads “Status updated” and the status badge changes to Pending Response. The header now shows the Draft Response Email and Mark Responded actions.

Confirm each attached partner’s FSVP file is complete before sending records to FDA

What you should see: The QI verifies (per 21 CFR 1.510) that each named partner’s FSVP file is complete before sending records to FDA. If a file is incomplete, the QI either downloads what’s available with a written explanation, or requests an extension from the inspector.

Download the response package for the attached partner

What you should see: One ZIP per partner — the hazard analysis, evaluation, and verification worksheet PDFs plus the partner’s supporting documents, ready to attach to the FDA response email or upload to FDA’s secure portal. A toast confirms the package downloaded. Each report PDF carries the QI’s name, the inspection reference, and the generation date in the footer for audit-trail defensibility.

Draft the formal response email for the inspection

What you should see: A toast reads “Response email draft created — review in Emails > Drafts”. The QI opens the draft from Emails, does a final read-through, attaches the downloaded package ZIP(s), and sends it.

Mark the inspection as responded

What you should see: A toast reads “Marked as responded”, the status badge changes to Responded, and the Responded date appears in the Inspection Details card — the audit trail now ties the FDA request to the QI’s response.

Close the inspection with an outcome

What you should see: A toast reads “Inspection closed” and the status badge changes to Closed with the recorded Outcome. The inspection record — with its linked partners and package downloads — stays available indefinitely for future FDA reference.

Download a partner’s response package ad hoc from the partner FSVP tab

What you should see: Same ZIP as the inspection-detail flow — useful when a partner needs ad-hoc documentation outside an active inspection (e.g. internal audit, tabletop exercise, due-diligence questionnaire).